K971824 is an FDA 510(k) clearance for the REACH FEMORAL HIP COMPONENT. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 4, 1997, 202 days after receiving the submission on May 16, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K971824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 16, 1997 |
| Decision Date | December 04, 1997 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |